Regulatory Open Forum

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Hello Thomas

Basic requirement for eIFU is that the intended user of the device is a health care professional. If this is the case, printed IFU (supplied with the device) can be replaced with eIFU. What the device manufacturer needs to set up for this is an eIFU system (computer system). The eIFU system includes the eIFU software and the SOPs on how the manufacturer handles eIFU in its QMS. The eIFU software provides direct access to the device IFU (in analogy to the device and printed IFU in one box). The SOPs control the upload and release process of the eIFU. There is also the requirement to set up a process that ensures that the device user gets a printed IFU on request within short time (7 calendar days in the EU).

To answer your question, the manufacturer's website can be the only source of the eIFU provided that the eIFU system is validated. It is advisable to separate the eIFU software from the website operation to avoid the regulatory implications on the (marketing) website, this can be done with the appropriate technical set up. 

Some additional comments:

• A device with a computer interface that allows access to the instructions on the device needs a second source for the instructions (e.g. the eIFU system)
• CD/DVD are not very common anymore, it needs to be evaluated in the eIFU risk assessment if the user has access to this technology

Hope this helps.

Best regards,

Hans


------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
8044 Zürich
Switzerland
------------------------------

Original Message:
Sent: 22-May-2020 19:55
From: Thomas Lawson
Subject: Electronic IFU options

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Hello Hans,

I hope you're doing well, and I do hope you are right that the ​basic requirement for an eIFU is, "the intended user of the device is a health care professional. If this is the case, a printed IFU (supplied with the device) can be replaced with eIFU."  Per EU reg 207/2012, it appears it limits eIFUs though to implantable devices and the somewhat vague 'fixed installed devices' (which with some Notified Body clarity, includes X-ray devices for diagnosis, CT scanners, MRIs etc., and their accessories).  Based on this attached overview by BSI though, it seems like the interpretation between Notified Bodies is a bit different too.  On Page 6 of the attachment (in the highlighted section) it states, "It is unclear if EIFUs may be provided for devices outside the scope of this Regulation (207/2012). BSI may consider EIFUs for these devices on a case-by-case basis and as per the requirements of the medical device directive. Manufacturers interested in providing EIFUs for devices that fall outside the scope of (EU) No 207/2012 are requested to contact their BSI Scheme Manager for further discussion."  Thus, it seems as though, potentially with MDR or otherwise, BSI is more on your side here (allowing more than 207/2012 alone as being the only eIFU policy).  Yet due to the eIFU offered advantages - having multiple eIFU copies open on different computer monitors available in the clinical setting, being able to expand their text (for visual clarity) and electronic word search functions available in eIFUs too (versus one paper copy that could get smudged, ripped or lost, at critical moments, during clinical device use), I at least do hope eIFU use in Europe is opening up more, and not limited to 'implantables, and fixed installed devices and their accessories'.  With that said, are you aware of any other EU Reg or Notified Body documentation that hopefully more directly overcomes these 207/2012 eIFU limits?

Your feedback is greatly appreciated!

------------------------------
Reuben Lidster
Regulatory Affairs Specialist
Bloomington IN
United States
------------------------------

Original Message:
Sent: 23-May-2020 02:58
From: Hans Strobel
Subject: Electronic IFU options

Hello Thomas

Basic requirement for eIFU is that the intended user of the device is a health care professional. If this is the case, printed IFU (supplied with the device) can be replaced with eIFU. What the device manufacturer needs to set up for this is an eIFU system (computer system). The eIFU system includes the eIFU software and the SOPs on how the manufacturer handles eIFU in its QMS. The eIFU software provides direct access to the device IFU (in analogy to the device and printed IFU in one box). The SOPs control the upload and release process of the eIFU. There is also the requirement to set up a process that ensures that the device user gets a printed IFU on request within short time (7 calendar days in the EU).

To answer your question, the manufacturer's website can be the only source of the eIFU provided that the eIFU system is validated. It is advisable to separate the eIFU software from the website operation to avoid the regulatory implications on the (marketing) website, this can be done with the appropriate technical set up.

Some additional comments:

• A device with a computer interface that allows access to the instructions on the device needs a second source for the instructions (e.g. the eIFU system)
• CD/DVD are not very common anymore, it needs to be evaluated in the eIFU risk assessment if the user has access to this technology

Hope this helps.

Best regards,

Hans


------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
8044 Zürich
Switzerland

Original Message:
Sent: 22-May-2020 19:55
From: Thomas Lawson
Subject: Electronic IFU options

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Thanks, Hans and Reuben. I have been reading this regulatory interaction/peer-education site for several years and this if the first time that I had a question of my own.

As I read 207/2012, the device that my client has fits with: (d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; 

What I am struggling with is that the client wants to use electronic IFU and the device does have a screen (a visual display) so that the IFU can be loaded on the device and then be called up as needed, but the user would have to stop the imaging that the device provides and exit the imaging mode in order to then call up the IFU. That would not affect the surgical procedure too much, but it would stop the device from being useful to the MD for a short period of time.

I guess then what I will need to do is update the risk management documents to assess a new risk resulting from stoping imaging (the purpose of the device) for a period of time in order to display the IFU on the device's screen for the physician.

Thom

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Original Message:
Sent: 23-May-2020 02:58
From: Hans Strobel
Subject: Electronic IFU options

Hello Thomas

Basic requirement for eIFU is that the intended user of the device is a health care professional. If this is the case, printed IFU (supplied with the device) can be replaced with eIFU. What the device manufacturer needs to set up for this is an eIFU system (computer system). The eIFU system includes the eIFU software and the SOPs on how the manufacturer handles eIFU in its QMS. The eIFU software provides direct access to the device IFU (in analogy to the device and printed IFU in one box). The SOPs control the upload and release process of the eIFU. There is also the requirement to set up a process that ensures that the device user gets a printed IFU on request within short time (7 calendar days in the EU).

To answer your question, the manufacturer's website can be the only source of the eIFU provided that the eIFU system is validated. It is advisable to separate the eIFU software from the website operation to avoid the regulatory implications on the (marketing) website, this can be done with the appropriate technical set up.

Some additional comments:

• A device with a computer interface that allows access to the instructions on the device needs a second source for the instructions (e.g. the eIFU system)
• CD/DVD are not very common anymore, it needs to be evaluated in the eIFU risk assessment if the user has access to this technology

Hope this helps.

Best regards,

Hans


------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
8044 Zürich
Switzerland

Original Message:
Sent: 22-May-2020 19:55
From: Thomas Lawson
Subject: Electronic IFU options

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Hello Thomas

I think in EU Reg 207/2012 articles 5(6) and 7.1 are the ones that describe the situation of your customer.

Christoph is right that the notified body needs to review your eIFU concept. In our experience companies submit a change request to their notified body when they plan to introduce eIFU. In the majority of cases this comes back with the statement: ok, go ahead, we will review your eIFU system in the next scheduled audit.

To Reubens question on the EU eIFU regulation (207/2012), there is currently a review of the regulation, status and timing unknown, however there is a position paper of a German medtech association which indicates the position of the industry. 

Best regards,

Hans

------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
Zürich, Switzerland
www.dokspot.io
------------------------------

Original Message:
Sent: 26-May-2020 11:50
From: Thomas Lawson
Subject: Electronic IFU options

Thanks, Hans and Reuben. I have been reading this regulatory interaction/peer-education site for several years and this if the first time that I had a question of my own.

As I read 207/2012, the device that my client has fits with: (d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;

What I am struggling with is that the client wants to use electronic IFU and the device does have a screen (a visual display) so that the IFU can be loaded on the device and then be called up as needed, but the user would have to stop the imaging that the device provides and exit the imaging mode in order to then call up the IFU. That would not affect the surgical procedure too much, but it would stop the device from being useful to the MD for a short period of time.

I guess then what I will need to do is update the risk management documents to assess a new risk resulting from stoping imaging (the purpose of the device) for a period of time in order to display the IFU on the device's screen for the physician.

Thom

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States

Original Message:
Sent: 23-May-2020 02:58
From: Hans Strobel
Subject: Electronic IFU options

Hello Thomas

Basic requirement for eIFU is that the intended user of the device is a health care professional. If this is the case, printed IFU (supplied with the device) can be replaced with eIFU. What the device manufacturer needs to set up for this is an eIFU system (computer system). The eIFU system includes the eIFU software and the SOPs on how the manufacturer handles eIFU in its QMS. The eIFU software provides direct access to the device IFU (in analogy to the device and printed IFU in one box). The SOPs control the upload and release process of the eIFU. There is also the requirement to set up a process that ensures that the device user gets a printed IFU on request within short time (7 calendar days in the EU).

To answer your question, the manufacturer's website can be the only source of the eIFU provided that the eIFU system is validated. It is advisable to separate the eIFU software from the website operation to avoid the regulatory implications on the (marketing) website, this can be done with the appropriate technical set up.

Some additional comments:

• A device with a computer interface that allows access to the instructions on the device needs a second source for the instructions (e.g. the eIFU system)
• CD/DVD are not very common anymore, it needs to be evaluated in the eIFU risk assessment if the user has access to this technology

Hope this helps.

Best regards,

Hans


------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
8044 Zürich
Switzerland

Original Message:
Sent: 22-May-2020 19:55
From: Thomas Lawson
Subject: Electronic IFU options

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------

Thomas,

I agree with Hans' comments.

I would like to add some color commentary to his points.

There are a number of options to supply an eIFU. What matters is that you approach the eIFU systematically (i.e., that you validate your eIFU system). You need to be certain that a clinician can access the correct material for the product. A website-posted eIFU can certainly work, so long as you can reliably direct the user to the location where that customer's specific device information is located.

The idea is to make eIFU access reasonably simple. Clinicians could always access your paper IFU, so you need to be certain that clinicians can still easily access your eIFU. 

Note that Notified Bodies play a role in overseeing whether eIFUs are appropriate for your CE products. Best of luck.

------------------------------
Christopher Phillips, MSHS, RAC, CBA
Regulatory Affairs Senior Manager
Cottonwood Heights UT
United States
------------------------------

Original Message:
Sent: 23-May-2020 02:58
From: Hans Strobel
Subject: Electronic IFU options

Hello Thomas

Basic requirement for eIFU is that the intended user of the device is a health care professional. If this is the case, printed IFU (supplied with the device) can be replaced with eIFU. What the device manufacturer needs to set up for this is an eIFU system (computer system). The eIFU system includes the eIFU software and the SOPs on how the manufacturer handles eIFU in its QMS. The eIFU software provides direct access to the device IFU (in analogy to the device and printed IFU in one box). The SOPs control the upload and release process of the eIFU. There is also the requirement to set up a process that ensures that the device user gets a printed IFU on request within short time (7 calendar days in the EU).

To answer your question, the manufacturer's website can be the only source of the eIFU provided that the eIFU system is validated. It is advisable to separate the eIFU software from the website operation to avoid the regulatory implications on the (marketing) website, this can be done with the appropriate technical set up.

Some additional comments:

• A device with a computer interface that allows access to the instructions on the device needs a second source for the instructions (e.g. the eIFU system)
• CD/DVD are not very common anymore, it needs to be evaluated in the eIFU risk assessment if the user has access to this technology

Hope this helps.

Best regards,

Hans


------------------------------
Hans Strobel
CEO & Co-Founder
dokspot GmbH
8044 Zürich
Switzerland

Original Message:
Sent: 22-May-2020 19:55
From: Thomas Lawson
Subject: Electronic IFU options

I have read EU reg no 207/2012 and various other EU and FDA documents concerning providing the IFU in electronic form rather than paper and while I understand the various options, what is not clear to me is whether the company may supply the electronic IFU only via a website (presumably the company's website) rather than have the website making the electronic IFU as just a backup to either a provided CD/DVD or in a device with a built-in system for viewing.

------------------------------
Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
------------------------------